Add to favorite
 
123
Subscribe to our Newsletters Subscribe to our Newsletters Get Daily Updates RSS


Clinical Trials of Insulin in Russia are Probably Fake
November 10, 2010 23:24


Former top manager of MannKind, an American biotechnological company, sues his employers for falsifying results of clinical trials of their anti-diabetes drug in Russia. Diabetes is a group of metabolic problems, due to which human body doesn't produce enough insulin to control blood sugar (Type I), or organism's cells do not adequately react to insulin produced (Type II).

Biotechnologists of MannKind company have been performing clinical trials of their new diabetes treatment in the Russian Federation and at the same time have negotiated with Moscow government about further cooperation. John Arditi, former senior director for regulatory affairs of MannKind company, accuses the company in misreporting results, obtained during testing the newest anti-diabetes treatment in our country.

Mr. Arditi's lawsuit is related to "Afrezza", insulin for inhalations. Insulin is a substance, which helps those, suffering from diabetes, control sugar content in their blood. "Afrezza"'s reported benefit is that patients with diabetes do not receive insulin with injections, but simply inhale it; insulin dissolves in patient's lungs and enters his blood stream. The inhaler is as small as palm of a hand. The drug, useful for patients with both types of diabetes is currently reviewed by FDA (Food and Drug Administration, USA).

 

 


Structure of insulin
The lawsuit, claiming clinical trials "scientifically negligent", is based upon several facts, one of which is same blood pressure in all Russian patients, who have participated in the trials, during several months of the trials. Mr. Arditi, who lost his job soon after he told FDA about suspicious trials, suggests the trials could have been based upon fictitious patients. However, MannKind biotechnological company denies everything and claims that independent experts didn't find anything wrong in the trial procedure and results.

Experts believe that John Arditi's lawsuit may be a serious problem for approval of insulin inhaler by FDA. The lawsuit has already caused a significant drop of MannKind’s shares. Former head of the Moscow government has met the head of MannKind's CEO Alfred Mann last year – the discussion between the two businessmen was dedicated to possible cooperation with the capital's health and biotechnological establishments in the field of treating diabetes, a serious and dangerous disease.

However, some experts think that insulin inhalations aren't a perfect solution for patients with diabetes. Delicate cells of alveolus aren't suitable for delivering insulin into blood stream, they say, because lungs were designed for dealing with gases. Insulin injections nowadays are almost painless, because insulin is injected with tiny and very sharp needles. Sometimes insulin is sold inside a syringe, which is very convenient, since you don't have to do anything with ampoules. Sometimes patients take insulin for tens of years, and consequences of a long-term inhaling of insulin are not studied enough, medical experts say.

Source: Gazeta.ru

Kizilova Anna


Tags: Russian scientists Russian science health Russian medicine  

Next Previous

You might also find interesting:

AIDS in Russia: what Scientists Think and what They Actually Do How Artificial Reefs Can be Useful? Russian Aeronautics Centre Happy 60th Anniversary Microexplosions Result in Nanodiamonds Parachute for 1st Domestic Commercial Spacecraft Worked on in Russia









Comment on our site


RSS   twitter      submit



TAGS:
Russian business  Ignitor  Stavropol Territory  Russian oligarchs  Cars  Historical Exhibitions  Russian tourism  Theatre Festivals  State Award of the Russian Federation  Smolensk  St. Petersburg  Mikhail Bulgakov  Moscow  Ski resorts  Vladimir Chambers  #OPENRUSSIANFASHION  Russian airlines  Russian media  chemistry in Russia  Russian scientists  Sokolniki  Russian science  Russian monastery  Russian Cinema  Orenburg region  Locomotives  Best European Cruise Destination  Domodedovo  Fashion week  Jean-Maurice Ripert  technology  Yandex  Samara Region  Russian economy  Suzdal  Mercedes-Benz Fashion Week Russia  energy drinks  Russian Steel Producers  Lana Del Rey  Nina Alovert  National Card Payment System  Tigers  Russian Monuments  Elbrus  Great Patriotic War  Apocalypses  Russian Railways  Elephants  Zenit  Exhibitions in Moscow 


Travel Blogs
Top Traveling Sites